Arcus Biosciences (RCUS) 7 Nov 232023 Q3 Earnings call transcript

Thank you, and welcome to the call.

Following prepared remarks from the company, we will open the call for questions. [Operator Instructions] This call is being recorded and will be available on the Investors section of the Arcus website.I will now turn the meeting over to Pia Eaves, Head of Investor Relations and Strategy.

Hello, everyone, and thank you for joining us on today's conference call to discuss Arcus' third quarter 2023 financial results and pipeline updates, including today's presentation of data from our EDGE-Gastric trial at the ASCO monthly Plenary. Today, you will hear from Terry Rosen, Chief Executive Officer; Dimitry Nuyten, Chief Medical Officer; Jennifer Jarrett, Chief Operating Officer; and Bob Goeltz, Chief Financial Officer.

making also Research.I'd by that our indications our like call, opportunity will population will and Jaen, on drug-treatable investigational we statements and and management of including pursued the clinical being program. Head to be and products, Q&A, our be cash any development Juan joined by President this about expected For our statements, milestones runway, timelines forward-looking of remind market you potential facts historical our than other risks differ. and cause statements All may that involve actual uncertainties to results recent uncertainties report been Those described risks and are the with Form in has our that most quarterly XX-Q SEC. on filed encourage to you filing. the strongly We review

of over For to which latest today's be deck, to please I'll corporate our refer turn the website.With Terry. our that, Investors call found call, section can on the

Pia, we've are who first Thank thank you on quarterly in is very had earnings some This the much, for you the all those, call and line. time.

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data and median show the achieved clear a contemporary just and differentiation months, for from XX our sufficient now data follow-up, data number Gem/Abraxane Furthermore, more OS synthetic we recent for to select we've to study we development need. setting, in to the Dimitry cutoff, mature, exceeded into diseases candidate the allergic were These highly year-end.So the over for in our our the the with AXL also a median turn X new call most earlier estimate. So for program properties of KIT expect set presented continue with advance one best-in-class also EDGE-Gastric initiated molecules that huge Phase detail Gem/Abraxane, very work the data selective for meaningful describe ABXXX, to control shows benchmarks just therapy.We by medical rigorous to events I'll combination today. clinic. differentiation our We now for potential from tirelessly inhibitor, which generated

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grade body potentially key related Zim. growing events for spend study, No serious minute antibodies.Before relative adverse shown the AE Fc-enabled vast I to expected fact, STAR-XXX, drug-related the XX% a from it XX a reactions Jen, In our Dom plus Overall, Slide all note, and elements chemotherapy were to profile anti-TIGIT safety design Phase These to on regimen to only the supporting were Slide of the of X treatment-emergent profile tolerability I X evidence well which some events shown to with results deemed adverse treatment-emergent a is on FOLFOX related or that or to over similar were contributed Dom #XX. were tolerated of to differentiated contributed or higher to of on to oxaliplatin. turn Zim.Of infusion-related majority was anti-PD-X. Dom and wanted add

First, than X% stratifying we than less are TAP or by greater X%.

between balanced well X treatment is this the So arms.

analysis our with have survival more of X the We of plan.Second, other study to the endpoints than TAP has one statistical more meets in score overall the TAP, these our are primary ensure and percentage for the of for also that the of X% ITT percentage monitoring percentage prespecified dual study than the of tumors a patients, the who closely for patients population. X%

about in turn that, for X TIGIT. opportunities to win it we study.With have talk over opportunity this Jen So I'll to the market to

overall. Dimitry. about like Thanks, start field to talking I'd TIGIT by the

KOLs is from feedback and growing recent an anti-TIGIT clear data-driven most therapy. Our indicates for innovative a enthusiasm

regarding X Following their of the sentiment oncology [ we from party release second to Roche's of analysis survey a a anti-TIGIT. data of the to conduct interim ] SKYSCRAPER-XX, on XX KOLs third engaged the

receive You and believe that XX respondents plus PD-LX can Slide likely atezo these anti-TIGIT on tirago approval. it deck.Approximately combination is will see Roche's investor of results for XX% FDA

patients opportunity anti-PD-X on increasingly first-line junction physicians. larger anti-TIGIT with value potential cancer. the based expect continue and indications, results anti-TIGIT we for Today's patients countries. cell the accumulates, standard survey change over mentioned, or this and pursuing adenocarcinomas by a in data adenocarcinomas, GX in convinced respective improve XX% across different PD-LX-high and anti-PD-X histology are being on approximately moderate successful.As to-date, Additionally, adding the to role almost of their mechanism for the the are physicians very which gastric demonstrate of studies. plus current as non-small pursued alone in the lung and telling, play BeiGene treatment esophageal results is Roche represent proposition a a is potential combining and outcomes they've market are Since no Phase to seen for XXX,XXX we a lung this cancer. X to $X the than Dom GE These chemo where that and the Note to toxicity, treatment anti-TIGIT X XX,XXX with in are billion-plus of evidence U.S. care, that, easy is Terry paradigm

In today's another gastric upper one anti-TIGIT there you for developed against GI the development in agents only types of cancer, also fact, being which in fastest-growing of aware X the directed are we Phase adenocarcinomas, first-line Western in were plenary claudin is and are Europe.Many cancer U.S. of which discussed is XX.X, and that class in session. the Gilead

of While XX% estimates are these anywhere significant XX.X, published literature encouraging, expressers claudin XX% GI molecules the of efficacy from and data associated are that toxicities. only or with to patients high

data to will rolled it we filings to to regulatory discuss similar potentially to treatment. expect to the years efficacy be any take have achieve best-in-class also indication.I'll back combination, avoid believe claudin need and to in for recruitment support secure successfully will the moving as anti-claudin position, several now and set potential for patients toxicity our study to CDXX are HIF-X to associated allowing testing, anti-TIGIT, first our we XX.X programs. We market turn we it out.With this a Today's aggressively the without for testing directly the and alpha both and and go Terry with

Jen. much, very Thanks

setting ABXXX. factor. is RCC. HIF-X a It belzutifan's VHL have really at few clinical first, The but So there primary let alpha. It's in that absorption high-quality It's first of to today.Belzutifan create cell binding XX It's of why That's ligand And Slide Merck HIF-X dose other deck to the limitation no the inhibitors, milligrams. are for molecules a on difficult to-date, it's me transcription clear are alpha describes and XXX level target. our blockers only start is bit also ideal result, substantial. has inhibitor simple. domain. proposition a the that against by only but a drug for development oral as it's HIF-X very although, be proven very approved filed of alpha associated saturate recently for approved belzutifan value approval cancers, corporate in first pretty properties

So exposure belzutifan not are what doses drug increase. does does meaningfully of Even mean? administered, when that higher systemic

just and dose of was that not In XXX their that at ESMO, levels. did fact, plasma because published that XXX-milligram meaningfully to with toxicity.Merck, for beyond fact, XXX results in nothing of X No chosen the XXX doses They milligrams XXX selection it's LITESPARK-XX dose-limiting surprises. This data there between approved was from released the had do versus belzutifan evaluated the in these their doses difference no higher clear very milligrams belzutifan. in of doses ORR milligrams dose trials. support concluded for results which of for milligrams result

did PK dose, for it's PD not this that However, and study. no they note important were XXX-milligram higher with or they drug they of any achieving data of the to exposure whether levels share super mention made

going -- months meaningfully harder. hit that were until of objective this more responses the fact, of the a in in of fundamental enabling So literature, half target this inability, view and PFS. milligrams, was study, above thesis an concentrations just for a RCC, to showed limitations without and as doses line achieve X.X% X.X-month belzutifan then versus LITESPARK-XXX program.The XX% These and XX% alpha us with of about the pharmacokinetic essentially liability, this previous to achieved not approximately ORR program recapitulated XXX or the more with X and Phase belzutifan's In a data ability into consistent PD we plasma are treatment. greater Everolimus second which Xb PK ORR our HIF-X create a primary our to molecule of for Phase clear these study cell were ORR X median belzutifan in demonstrated evidence

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XXX of year, There great have at well safety and been cell XX or in efficacy milligrams as data, PK, So portion XX-patient next the initial all in of a deal our we've study. XX at the the daily. RCC the opportunity fact, have is in patients dose very enthusiasm to patients around investigator data, as study. clear the cohort expansion of XXX has milligrams based from milligrams were pharmacodynamic RCC, Approximately we're enrolled.Early excited these a daily these half of almost the to a cohort the of initiated dose And present data dose escalation on treated fully patients.

to an target the relative coverage these our of does relevant.The both increased liability. safety not support view in belzutifan So are safety result doses ABXXX obtained pharmacologically enhanced by by data that that

to from differentiator enabling advanced clinical bound it of Quemli small of ] the is in to and because development levels shed antibody compared soluble readily is membrane activity. resulting CDXX to data the cohort combination X talk year-end of CDXX, Phase possible.So and TKI soluble molecule expect as study, second also that's cancer. is achieve difference next in present in with CDXX. evaluating CDXX goal study both a potent molecule blocks about to quemli study it significant over quemli forms Phase to now metastatic selective We're the ARC-X. study CDXX. expect extraordinarily the This our expansion from the a We in as complete for a a year. the RCC progressing highly in cells, first-line huge Really X is that inhibition getting by rapidly of cell clear of Phase start quickly enzymatic X/Xb excited the inhibitor me line shift of most ABXXX A let to key this [ pancreatic

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cancer the the in really high part need. of Quemli up formation and results market a exceed development fibroblast it and quarter. decade.As inhibiting advancing Bob billion.I'd patients disease be pancreatic response you review better States chemotherapy a essentially by and believe $X field XX,XXX fibrosis. by and patients may believe for interfering these in It with in enhancing to extremely cells, we advances this this data, adenosine global to the for of cancer tumor; opportunity in tumor been United about response from easily There's blowing excited is unmet devastating like T very the cancer. really cell a no the the biology turn with and well-known First, could of our further We're affects effects we know, to alone, support financials we with now in over to the second,

Thanks, very continues strong position. financial Terry. in Arcus to be a

through $XXX cash end was at been Our and quarters million. million, of utilization net $XXX XXth, X XXXX, has the cash XXXX our of September

to Importantly, large costs be we portion expect cash on our our partner, $XXX XX-XX We to we for our $XXX million all our and now of year down share our ongoing to into guidance $XXX $XXX X portfolio, studies. a prior balance Gilead, million, and operations continue from between XXXX. including fund with of million full Phase expect million, XXXX of cash utilization to

which compares $XX the GAAP Our quarter this of our million, and guidance to potential opt-in cash revenue runway million for of year. excludes payments approval P&L. We recognized $XX this second milestones from partners.Turning quarter to for our

received STAR-XXX related Taiho payment updates collaboration our in to with of in milestone Gilead, fourth participation to will In by with partnership first levels to the Gilead, Dom their Our million small from a revenue we development fluctuations plans pivotal $XX the the for $XX driven Japan. primarily to and receive million is XXXX. timelines.In partner maintain quarter quarter, near similar term of our another revenue with our in and to is study expect in addition of clinical we Taiho our and our due

$X of net reimbursements second for R&D the from are represented Gilead expenses. million, million the quarter expenses this In stated from current are R&D quarter to as related year. and compensation of payments quarter, eligible compared to STAR-XXX.Our in for additional stock-based We third $XX Taiho also the were non-cash of milestone our $XX million

R&D We expenses, our as studies Phase expect our X modest increases in mature.

our clinical fluctuate for the purchase may timing trials. standard on care activities based spend and the of therapeutics clinical However, manufacturing of of

XXXX compensation these For XXXX our example, release remarks. was and quarter, quarter and over for Terry of $XX represented expenses the million compared earnings refer $XX our the from today in G&A of this regarding second remainder areas through for stock of to details to spend quarter, the this expenses of in XX-Q.I'll to lower earlier expect please preceding quarter over some XXXX.For the in remain stable to quarters year. and than results, the G&A third year.G&A more our of we our back in million call third Non-cash financial $XX for the million closing turn press this were now

Thanks very Bob. much,

to ongoing anti-TIGIT up, first support setting X Dom/Zim be as more Both of to we combined execute continue and also -- HIF-X-alpha anti-TIGIT, really if have Dom, excited evidence we're to set. it profile,As on efficacy time. we're a profile of to in really holistic supports our anti-PD-X, and term in looking programs it's to sharing provides today's So to wrap and data Dom, distance near we Phase well forward the really trials quemli adenocarcinomas, remainder been an first to best-in-class off, the pipeline, a pancreatic bit, safety a a in best-of-class advance It the by as anti-TIGIT track for program. data important X a we're very elevate these on some in you our our for of cancer on about market potential continues that GI Since market first-line first that and antibody. with upper

develop, for thank combination support, think floor we are I that some can as we're both.So patients for believe, open for to for to work as innovative need,With look I'll in really data we questions. with that, I'd have very you continued the cancer that, you therapies going inflections like your up that to at

[Operator Our Citigroup. Nochomovitz comes from from Yigal first Instructions] question

for the the on and a that I -- to And you low. the prespecified design for comment, just stats high what plan around Dimitry you comment to TAP is it of you've in on to wanted follow that TAP similar EDGE-Gastric? percentage in Can up seen Dimitry, you STAR-XXX. made mentioned is? the what

for Thanks the question.

I number about of the before, people high standard general criteria around expecting patients, to analysis details. power and to say, my specific the want said groups.What comment in comment a because number do is plans slightly as designed those number be of to and that are on In survival events sure a look specifically the turn trial lower statistical high I've both is, I have made So want order and thereby, what PD-LX is don't -- overall of population. the exact the population for can in I the at we to that, analysis the we patients. we I

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endpoint it And on Or do does have you PD-X how a on have overall? the primary -- is Do work? high? the the primary you a

Both.

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be and So the tested declared of either positive. positive study both those if will one is be can independently,

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Just can you on that Do you with hypothesis? comment agree that?

so, that. I I'll Yigal, think take --

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one less you comment better than compound can giving the quarters. Okay. thinking that pathways to was that the I engineered you that What interested gastrointestinal argument driving for all was or Can several Merck you've hypotheses have mean, at avoid Got then -- to? about on that or that? PK just are features edge protein the keep And better you of I a made on Terry. you you design I'm some bit absorption. XXX, to it. little comment what's what you've metabolic binding -- you maybe referred introduced certain as

Yes.

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Evercore question next at ISI. Our from Jonathan comes Miller

call. sense in I it read. HIF-X. that guess, harder does target know exposure got I I the does, outcomes as we it better Merck yet you've that the let's on result makes during what Terry -- guess up mentioned than is that take make really hitting follow But don't better I'll

efficacy So data for data that? addition we additional is in the signal better clear to Is it gives of what escalation my PD. that we Or I in could does in guess later likely year? that get that question something wait to have expansion do us

great Thanks, question. Jon. a It's

the course, key Of question. the -- that's

I as think of from data the our well the with arguments own the that data we as make factors are Merck combination a molecule.

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harder example, had the that much. expect might would much target could for you you an you that ORR results.So see that hit XX% you probably buy wouldn't if So and you was stronger

on they to hit and you what harder. know finish our of if come can't that We me we the all, molecule, molecule. first their about let know target Now,

usually is easily know, at multiple using to get or is effect higher have to the in dose that fact, dose used that's something look they pharmacodynamic by endpoint, And that gets oncology, the now at that we're about in X/X Merck a that if And fourfold either you dose. ways MTD. modeled you been shown, can't as in their their the with basically, demonstrated X/X exposure. that's dose. forward detectable, we go same we case, you've In fact, can in So them.What you've an clinically simply get the hit

the a to be patients like or half able the from asset, a the patients question that mind, should late we patients. we our very you to see obvious is data, has more hitting that see a the trial, and It's that good feel you'll pick working. will the And certainly, that that itself.From molecule said harder. randomized be those of out than So in study going well of now target that you'll half behaving clearly, looks group then is heterogeneous. roughly escalation manifest do little -- we get XX in large a it that's keep RCC, drug line be But a

say So the Phase harder. I in hitting we is will be we much think real be what the that would X expansion cohort that target might better would how the of sense the we that one by data get doing true

TIGIT. the results. this then, It And afternoon seems sense. very about EDGE on excited I guess the makes plenary discussion That Great. like wasn't

this is because how think I PFS at early of curve point. the

coming PR well? that -- fair Is your suggests series year But usually is comes updated get know at to PFS to PS coming plenary half. presentation. mature is virtual I second PFS we'll expect it as the the next that ASCO So ASCO

We look back to encouraging. the the data. me just let first, think quite come So data actually actual

high know, of the PFS you quite as as the the both well totality were the population. meaningful, patient X-month and in mature PD-LX, As they're

the if meaningful. the about look landmark XX% PFS you example, quite clearly, So quite XX-some-odd go for percent think ] even is for on is of X.X PD-LX the you months and, back at -- And it, in sorry, that [ high X that's the X the CheckMate and X to study, I'm high. to what months PD-LX you've months, got order months is a median meaningful.If PF

we our far are year. we pretty diluted.With in to know. mature in median -- our that XXX% would expect XX% we're has we if that PD-LX We said, in next total been to bodes like compare second be PFS well X So do at and not landmark at to population, which still as expectations, you it guidance what start months, even of the so half be high

obviously, see, of as We large, study. to have the remain a just that's a event-driven. saw, we'll patients on large So number had you

we'll as see along. that year the how out, goes So plays

in But have the summer at well? do presentation as a you ASCO

Absolutely. Yes.

Hi, everyone. This is Pia.

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to you you HIF-X test [ alpha. think in we're PFS? XXXX, see OR? emerging, your going Just do think starts on differentiation emerging ] that do in data early Terry, of that we wait to kind The have it it's Or -- to see whether

don't I ahead, Yes. -- go Jen.

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do So to those those of half have X approximately going so patients, is approximately the XX dose patients be escalation of RCC. patients,

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Truist. from is question Karnauskas Robyn next from Our

very in I of questions. them time. XX have do you Great. can hope period short I all a

Robyn, you XXX can have question. a

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once keep in introduce mix, a you So to you aspect chemo levels of this situation, that's have you dynamic that is mind and therapy. one PD-LX -- the with an thing into sort of get important

surprising not immunogenic if you discussions, talk and chemotherapy about it's So of the doesn't. one what heard that

think -- what talk immune can have might have who now you talk ] we you tumor something not a can be even much So a an and from we this enhance survival lot but because if patient, of you a standpoint might good context of really a about on immunotherapy, about response, reduction, mount they generate a number that surprisingly get response, [ T the can of in response.And can it. this benefit we can quemli, an cell if you since immunotherapies, a I work have it's

feel for the XXX% immunotherapy Robyn? in just certainly the your tell levels that's rationales that second that, we story.What chemo was when the with So bringing amongst PD-LX you start don't of question, together

a for pancreatic seems time the follow-up of months, time? context? like a the pancreatic long XX So Is that trial, do we That how long for if into you with like that -- median cancer. put

like what be months high months to to X And on XX Yes. that Yes. a OS to think is, the between the time. long end. median clear, about when we It's range tends somewhere readout

was given If you to be that devastating, months meaningful. talk months even to something that than clinicians, is this longer would so X X

moving we're it's really going that have to something the think we like looks needle. So

queue. All put X back another Enjoy. the in questions -- I'll my right.

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at Pohlman question next is Kaveri from BTIG. Our

on the And EDGE-Gastric congrats trial results.

for TAP score the about could For rationale your was PD-LX color it your for can rationale or tell using versus cutoff us Also, expression, is X some can X like from on CPS for other you how the have you provide XXX that of And different if assessment? trials used trial? any used? using

Thank Dimitry that. will take you.

Yes.

words, published is XX the It need there's CPS the for [indiscernible], is there's those we purposes, a to of regulatory So the the been the pathologists, in years XX-plus of a different right? of have and and rationale need assays. method, So things, done have scoring that work do. for She it's range. as done TAP single the the different every cannot BMS's in to it concordance scientific pathologists as great. who not trial of has CPS looking be work companion CPS scoring to assay. an comes easier inter-observability a was of answering with work That it at SPXXX.When factor diagnostic if initiated way for CPS, you couple therefore, to trial. those a official training, and is use But at didn't my That's stratification is kind which as for to simplest the assay method. and there's TAP combination then strong said why look question use discussion in is, rationale. but we XX% the a practice XX% got the that And we

to and So domain. easier TAP more CPS a the is think was somewhat so that setting, question... threshold in implementation lastly, I a of reasonable the in then good think for data extrapolated it's We the The there one larger from public is a threshold.And implement. threshold X% part in -- the is CPS benefit has challenging

it. I think that was

No, that was it.

Okay.

everything, get we Do Kaveri.

Sorry, no. easier. showed TAP we right? to the the want is I concordance, And point, So make

well that let's by on our assays patients say, is these corporate the X data it between it CPS makes we data as both that confidence trials. captured also methods. on widely not the a have set the concordance beyond number But high deck think I the, clinical provide easier in a implement that to own larger to scale of provided different. There's

just one squeeze can if it. Got And I more.

For us around arm externally some with about made you synthetic from color ARC-X control comment sharing you that? Can the generated give data trial, Gem/Abraxane.

your mean, I'll rigorous It say matched well-annotated population assuming what X,XXX is, large matched everyone particularly that that aren't give the that that done of lot your And certainly quality I set. even or patient metadata. is you a in to couple the they about bring get took it.So you think going patients a of and is the data of extremely And And of -- confidence. going actually, This was quite very part to think they surprised have which I even done set better it's make that that pleasantly that an to set, minimal. do. to be set patients. much by analysis in type I when patients, a plans data I'll standpoint, enough a that's months they was you that do forward. it you reality control regulatory sure data think start going was a like just very can do agencies could to get discussing even of to to way, take XXX frankly, with data trials from more

program. we So for package big be that's part in think of to going that a deal our total

Mara Mizuho. comes question next Our from from Goldstein

Great.

facilitate hope that there -XXX presentation a would today, a data. There's the help STAR the this enrollment. was this comment along of plenary the During lines also of

characteristics perspective? So is that looks the here? And can what bit from you trial talk from a like little where timing about enrollment

Yes.

we I enrolling though a is question. trial line you love the answer, the gangbusters. So can't bottom give Even

it it's So oh, like, isn't when much it's need in incredibly we talk about enrolling so It's that how help. of well.

than say going In would be first probably you more our to and ask read not, trial to go out. fact, to us that's bet, if that I think likely I

that well the couple will but ahead trials been our schedule.A be, ] [ let's guidance, enrolling has it's say, not of our of XXXX reasons. We're changing guidance Our on plus. comments

of from of a in need. unquestionably.So clinical There's just there's also it's as going trial a believe not that spoken what's think a the all and accelerate to field. there's just lot we are really investigators think going lot the lot excited innovative particular to been you simply could and whole data the an TIGIT we set things enthusiasm we've setting, on tell the sense, I of this discussions, about that's data-driven, further. happening the in In data,

keep I this. eye So an on

I this, field. think what's about you when about the interesting think holistically

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next The comes question Partners. Leerink from Daina from Graybosch

do to This you you these is think the share beyond Dom Jeff data was that Fc explain I of at [ various TIGIT else Phase the mean, ESMO? on presented differentiating the could from we that antibodies characteristics function the for you arguably potential Daina. Do to thoughts relative ] saw points? disappointing think recently competing ociperlimab, X could what on TIGIT your antibody

Yes.

to as mean, think a differentiator. I I that to So going key primarily, Fc we're come being

but the get you deplete they this T-REGs. absolutely until it's that clear empirical you data, So do and anti-TIGITs, wouldn't Fc-enabled know

And so a that's by be definition, good to not thing. going

AEs.But anti-TIGIT. because And for If realize you of fact, anti-TIGIT surprising the deplete different. advantage about asking tumor.So not going T-REGs dose is higher Fc expression. way is you is you're the to the The you safe expression. CDXXX I immune enabled you high questions actually about spectrum end mechanism a out on in as see just is periphery, tumor-specific a to telling. we the have thing by when because being think turning BeiGene over the have it's TIGIT enhanced one that see sort the it's the that a CDXXX it's in is where to that survival shock And mechanism, what it's of think of secondarily, expressed, fundamental key have -- people keep

to focuses want you CDXXX. everybody PD-LX. analogy, the draw of you If correlate know an on how PD-LX is

the But not that, the higher not of simply anti-TIGIT, don't driver. on-target that's particularly an T that's the forget you're of mechanism. with it's that it's So depletion -- then cells, PD-X dose, driver, a that an Fc-enabled that's component TIGIT, getting

is dose, in higher look and more. a going to okay? people end data fact, spectrum.What's the you these is expect [ see addition And telling to sort of this where forest by the trees. in ], the to at we on of point BeiGene So the higher would So

vibo. lot a is as about just And is not this it's XXX-milligram in more using speaks co-formulation. to that that And And they're you far, vibo, talking Merck about on-target setting. know, point And they more protecting not to AEs. of likely explored up It's were so dose And pembro. milligrams. XXX using we that of a XXX-milligram in pembro. surprisingly, But co-formulation explored Merck you give a dose co-form, going dose just the this that is

And -- think we that's as so, it's that. as simple

I is just second out the think to and other ociperlimab, presented that tended thing, will we're particularly the at anything and one be very line and was point was doing, I data different in ESMO printed after going setting. they settings

was data presented cell So squamous carcinoma. line cervical, esophageal line their second second

tumors going have I a very esophageal.But gastric like where the of and different you progressing we're pursuing sort months X of histology that So PFS after a chemo without with rapidly, line that to said, setting X months. second are

the they've their very is ours. at you different been and that only been settings ociperlimab, tumor but not pursuing have when So look plan types than there development antibody and different

comes Li question Cantor Watsek next from from Fitzgerald. Our

on Rosemary This for is Li.

So a patient in have to the PD-LX not hypothetically, for if PD-LX the approved hit the given for status comers, factors? you still you all you chance high endpoint to do get subset but the is survival stratification patients, that STAR-XXX, think were that for

very those that endpoints. for opportunity. Dimitry of just meaningful Both exactly co-primary for approval. detect we think trial that. [indiscernible] the is That's that was was think a both study it we designing both way for to So opportunities the it's don't designed the talking is And -- set opportunities the know are up we about

next Our Richter is Salveen from Sachs. question Goldman from

This for Salveen. on is Matt

share PFS actually tracking? share And you you on On share could on of then, improvement And more IO I X meaningful standard is months a view do how you're going an of Keytruda care? currently to combos? X the breaks And next the to data, treated gastric how you year? and median months care over as with know standard anything TIGIT patients are combo? most of anything between could down current what nivo

of questions. lot a That's

is benefit reimbursement be and of where and hasn't reimbursement reached. typically profile for would higher.Your the And median follow-up toxicity to There's manageable. We need reach median, very definitely an for with about is markets, treated especially where most what the on and in high case, investigators, that expressers depends are the investigators of it There So X% in the expressing, focuses U.S. question for when come issue. benefit have on what the it events plenty regimens wait nivo-based combo, the is comes and and significant is. more to a an you you to structure reimbursement PFS, can't are, patients median we is, calculate our IO anything experience of that Kaplan-Meier to there don't low that. been it. about the modest say to there that really number to a for everyone because testing course, The give of requires

can probably get that would very very, obviously, looking to higher. let's ratios numbers away I the we they And months, what X nothing X.XX When that you another there. in in promising. we now a in think So single-arm trial. bit much right [ had the we I that as there's emphasize Phase think are we setting.I by it look from up we starts that's say very comes medians should say. to have significantly except the in PFS interesting on a comes be actually the it about reaching.When If to hazard me that question meaningful benefit be absolute a X. to same I range and differences is to will a a question improvement, the survival think That's in hazard Phase at the be hard state can say, for as survival, ] then, ratio little benefit

approval think was was, One their their nivo of share that is that's vast conducted for will X. nivo gastric. PD-X our majority Phase in for assumption think dates But for filed to versus have in markets I is And the comparator December. continue with Keytruda And in approved, is only maybe PD-X here nivo pembro the question other KEYNOTE-XXX gastric. And study. mix for today, of the later. I PDUFA the market our that the

that -- worth or year highlighting is evaporate other One just thing that Fc somehow questions -- something overnight which the it's versus continuous sometimes non-Fc, evaporated. I like like somewhat a question probably and because for X was

I Keytruda think to another Zim it I'd evaporated, is comparison. that's like the but address one

approval as set you would I clearly data that in was think to just looks also of I performance think -- behave. the behaving an expect another example one the is Zim that's anti-PD-X It China anti-PD-X good. recently. got another But another

Our America. last from Zemansky of Jason from question today for comes Bank

this taking the I question. and Congrats appreciate on the quarter progress

algorithm was ESMO, here the was paradigm equal to both one that the in that evolve likely So over kind X, how any in move would claudin And benefit. agents I positive patient, one who synergistic get the I have than of would of CPS combining is ask, big potential of to or greater towards to the also gastric. treatment takeaways debates think big during obviously

are claudin of I obviously, particularly about I'm combo, need curious, mean, starts but enter you type you Now in to of PD-X do still favor this already the position KOLs very thinking to combination, TIGIT, a TIGIT do how what as it's biomarker-driven? to if is discussion working the evolve? to conversation early, are as

-- of about and think I lot a KOLs anti-claudin, time the same spent talking KOLs we're I mean, And we've companies for Yes. working with are. with anti-claudin the

interesting, today, that literature there thing look expresser. if high patients, of that outside claudin that in high So only puts are that XX%. reason. you're if are that -- hunch XX.X at was to of other in is, prevalence is below we've But CPS cited first that's more also Asia, statistics was high lower.The look in XX.X XX% claudin is the you of And seen heard that like number say patients seems there XX.X out percentage a you the of which that I'd for prevalence well be number XX%, antic-claudin, thing And of know, [ there's low of claudin ] literature, the high claudin some high prevalence is spotlight. we've the the patients if are about that PD-LX I my XX.X at

So I'd they may even toxic. that at [indiscernible] obviously of look people competitive. piece, just when less that, much looking say anti-TIGIT at anti-claudin, versus top be directly we're on not

So if with plenary the advanced presentation lot toxicity antibody They talked clinical particularly which the in of antibody, ADC. some seeing Astellas' obviously other in the they're there's look you of development, a the is toxicities the at most GI today. that about

roll talk think third and because There's years PD-LX happen on And today testing as else X XX.X it's we feel going or to that piece They that keep is provide relatively safe out. treatment. want sites not mind.And test of does don't to KOLs, for take So that's just to is agent. I to up right even a lot PD-LX in the or then test, like a more for going to something to they PD-X patient I'm not to the today. claudin

going him just anyway. I'm so, And antibody to PD-X give

think to anti-claudin. do out roll to impediment is we the be testing need So uptake going of another the to

very feel ADC. eye road, and into class. PD-X think least compete today, our very, there's But anti-claudin anti-claudin, to chances down I TIGIT very well So we with potential a the and combine to on claudin keeping good way maybe as we're the about the at a definitely close

Yes. people encourage want what to typically talk that, to And I do look to and but would right? up it So toxicity means. add about actually grades, I you

antibodies, claudin XX% and the have or X at they grade vomiting. XX% least nausea So

be made, like, patients Jen of yourself it's field. funneled population. subset really is that a I nausea and question, tube points deal and into patients, a I the hospitalized, uphill you parental PD-LX is If promising. And the vomiting X you're burden to that's ask grade that's you're think on to with toxicities big data for get another on We could small you deal.So as battle the high but then means It's a grade a obviously really, X efficacy that claudin big the really nausea that But talk claudin really, absolutely X Obviously, deal. you are feeding. think hit about feeding, the high that X grade patient, going and honestly, a vomiting.

is with. to incredibly to have that -- toxicity deal think I patients for bad incredibly

This concludes today's conference call. joining. for everyone, Thank you all,

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